Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-24 @ 8:21 AM
Study NCT ID:
NCT01397357
Status:
COMPLETED
Last Update Posted:
2016-10-03
First Post:
2011-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-30', 'studyFirstSubmitDate': '2011-07-18', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2016-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Cardio-RM identifying ischemic territories', 'timeFrame': '1 month', 'description': 'Assessing the accuracy of Cardio-RM identifying ischemic territories and their correspondence to the presence of critical coronary lesions, comparing the presence, extent and regional inducible ischaemia in the Cardiac-MRI with the presence and characteristics of vascular lesions in coronary angiography.'}], 'secondaryOutcomes': [{'measure': 'correlation between resonance and coronary artery disease documented coronary angiography.', 'timeFrame': '1 month', 'description': 'comparison of diagnostic positivity for inducible ischemia assessed by Cardiac-MRI and the presence of coronary lesions of various degrees evaluated by coronary angiography'}, {'measure': 'topographic correlation between ischemic territory and coronary lesions', 'timeFrame': '1 month', 'description': 'topographic correlation between ischemic territory assessed by Cardiac-MRI and coronary lesions evaluated by coronary angiography, using the criteria defined in Sintax study and BARI study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardiac magnetic resonance', 'Myocardial Ischemia', 'Coronary Artery Disease', 'suspected Myocardial Ischemia'], 'conditions': ['Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate CARDIAC MAGNETIC RESONANCE UTILITIES IN THE ISCHEMIC HEART DISEASE as topographical correlation between ischemic territory injury and coronary angiography.', 'detailedDescription': 'Assessing the accuracy of Cardio-RM identifying ischemic territories and their correspondence to the presence of critical coronary lesions, comparing the presence, extent and regional inducible ischaemia in the Cardiac-MRI with the presence and characteristics of vascular lesions in coronary angiography.\n\nIn particular, the study aims to evaluate the correlation between topography and function of the ischemic area revealed by the resonance and coronary artery disease documented coronary angiography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who refer to the clinic within 12 months, with diagnosis of suspected coronary artery disease (CAD) or recurrent ischemic symptoms assessed by under-effort angina symptoms and/or cardiac conventional stress test, and the presence of at least two risk factors.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with suspected ischemic heart disease or recurrent Myocardial ischemic symptoms defined as:\n\n * presence of:\n\n * chest pain related to the effort lasting 5-20 minutes, and / or\n * positive stress test for inducible Myocardial ischemia\n * presence of at least one of the following risk factors: smoke family history of cardiovascular disease hypertension dyslipidemia diabetes mellitus NID / ID\n2. no contraindications to perform coronary angiography\n3. informed written consent to the processing of personal and sensible data, signed and dated by the patient.\n\nExclusion Criteria:\n\n* Unstable angina;\n* Severe aortic stenosis\n* Hypertrophic cardiomyopathy\n* Pacemaker and \\\\ or defibrillator\n* Coronary stent implantation in 90 days before Cardiac MRI\n* Intracranial metal clips\n* Severe hypertension (systolic blood pressure\\> 240 mmHg, and diastolic blood pressure above 120 mmHg)\n* Ventricular thrombosis and \\\\ or atrial\n* Aortic aneurysm and \\\\ or aortic dissection\n* Myocarditis, endocarditis, pericarditis\n* Critical stenosis of the left notes\n* State of severe anxiety or claustrophobia\n* Contraindications to the use of atropine (BAV advanced glaucoma, pyloric stenosis, prostatic hypertrophy)'}, 'identificationModule': {'nctId': 'NCT01397357', 'acronym': 'CARDIO-RM', 'briefTitle': 'Cardiac Magnetic Resonance Utilities in the Evaluation of Ischemic Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ettore Sansavini Health Science Foundation'}, 'officialTitle': 'CARDIAC MAGNETIC RESONANCE UTILITIES IN THE EVALUATION OF ISCHEMIC HEART DISEASE: Topographical Correlation Between Ischemic Territory Injury and Coronary Angiography', 'orgStudyIdInfo': {'id': 'ESREFO02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'suspected Myocardial Ischemia', 'description': 'Patient with diagnosis of suspected coronary artery disease (CAD) or recurrent ischemic symptoms assessed by under-effort angina symptoms and/or cardiac conventional stress test, and the presence of at least two risk factors.', 'interventionNames': ['Other: Cardiac magnetic resonance - CINE MRI stress test.']}], 'interventions': [{'name': 'Cardiac magnetic resonance - CINE MRI stress test.', 'type': 'OTHER', 'description': 'Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.', 'armGroupLabels': ['suspected Myocardial Ischemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48010', 'city': 'Cotignola', 'state': 'RA', 'country': 'Italy', 'facility': 'Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ettore Sansavini Health Science Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}